Service Required Testing.pdf

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Attached to
Q301--Research Laboratory Testing Federal contract opportunity
Solicitation number
36C25725Q0716
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

About this file

The file is a comprehensive listing of in vitro and in vivo research testing services covering multiple scientific domains. The document details three primary service categories:

Tier 1 in vitro ADME services include solubility testing (aqueous kinetic and thermodynamic), partition coefficient analysis, microsomal clearance across multiple species (human, mouse, rat, dog, pig), and plasma stability testing. Tier 2 services expand to include P450 inhibition screening, plasma protein binding, permeability testing using various cell models (PAMPA, MDCK, Caco-2), and suspension hepatocyte clearance. In vitro toxicology services cover cytotoxicity testing and Ames testing. Additional services include analytical services like LCMS method development, in vivo services such as pharmacokinetic analysis across different mouse strains and rat models, MTD determination, and advanced ADME services including CYP induction and UGT inhibition studies.

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Text version

Tier 1 in vitro ADME Solubility aqueous solubility (kinetic) aqueous solubility (thermodynamic) partition coefficient (LogP) distribution coefficient (LogD, pH=7.4)

Microsomal Clearance human mouse rat dog pig

Plasma stability human mouse rat

Tier 2 in vitro ADME P450 inhibition

P450 inhibition (screening, single isoform) P450 inhibition (combined screening, 1A2, 2B6, 2D6, 3A4) P450 inhibition (10-point Dose-response, single isoform)

Plasma Protein binding human mouse rat

Permeability

PAMPA

MDCK bidirectional permeability MDCK-hMDR1 bidriectional permeability Caco-2 bidirectional permeability

Suspension Hepatocyte Clearance human mouse rat dog pig in vitro Toxicology cytotoxicity (HepG2) cytotoxicity (primary hepatocytes) Ames test

Analytical Services LCMS method development and calibration preparation and LCMS analysis of plasma samples preparation and LCMS analysis of tissue targeted multi-metabolite anlaysis: plasma and biofluids targeted multi-metabolite analysis: tissue Formulation development (solubility screening) in vivo Services RACE analysis (2 timepoints, 2 h, single dose, single route of administration)

1 miceCD- C57BL/6 mice Balb/c mice Sprague Dawley rats

Comprehensive PK (8 timepoints, 24 h, single dose, single route of administration) 1 miceCD-

C57BL/6 mice Balb/c mice Sprague Dawley rats

MTD determination CD-1 mice C57BL/6 mice Balb/c mice Sprague Dawley rats

MTD determination and single-dose tolerability CD-1 mice C57BL/6 mice Balb/c mice Sprague Dawley rats

7-day repeat dosing tolerability CD-1 mice C57BL/6 mice Balb/c mice Sprague Dawley rats

Advanced ADME Services CYP induction

High-dose screen, single isoform High-dose screen, 6-isoform combo Dose-response, single isoform

UGT inhibition High-dose screen, single isoform High-dose screen, 5-isoform combo (UGT1) Dose-response, single isoform

Drug Transport Hepatocyte uptake Hepatic transport inhibtiion

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